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    Clinical Trial Results:
    A MULTI-CENTER, OPEN LABEL, EXPANDED ACCESS TRIAL OF MARAVIROC

    Summary
    EudraCT number
    2006-004306-50
    Trial protocol
    IE   GB   BE   CZ   DE   PT   ES   NL   AT   GR   IT   DK  
    Global end of trial date
    30 Jun 2010

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Apr 2016
    First version publication date
    29 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A4001050
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00426660
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 East 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Nov 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the maraviroc expanded access program is to facilitate access to maraviroc for subjects, who have limited therapeutic options and to collect safety data in a larger and more diverse patient population than that which participated in the phase 2/3 clinical trials.
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of study subjects.
    Background therapy
    Maraviroc dosage was adjusted according to optimized background therapy (OBT). OBT was selected by the investigator on the basis of local treatment guidelines, treatment history, resistance test results (if available), safety considerations and his/her clinical judgment. OBT was open-label and not provided by the sponsor. Investigational antiretroviral agents available through pre-approval expanded access programs conducted by other pharmaceutical industries sponsors or in Phase 3 or 4 clinical trials or by other means may be appropriate for use as part of background therapy. Subjects experiencing toxicity attributed to drugs in the background regimen were allowed to substitute another antiretroviral agent during the trial. All concomitant antiretroviral agents were recorded on the appropriate CRF.
    Evidence for comparator
    -
    Actual start date of recruitment
    21 Jul 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    Portugal: 8
    Country: Number of subjects enrolled
    Spain: 132
    Country: Number of subjects enrolled
    United Kingdom: 18
    Country: Number of subjects enrolled
    Austria: 4
    Country: Number of subjects enrolled
    Belgium: 38
    Country: Number of subjects enrolled
    France: 193
    Country: Number of subjects enrolled
    Greece: 11
    Country: Number of subjects enrolled
    Ireland: 2
    Country: Number of subjects enrolled
    Italy: 154
    Country: Number of subjects enrolled
    Australia: 30
    Country: Number of subjects enrolled
    Canada: 13
    Country: Number of subjects enrolled
    Chile: 4
    Country: Number of subjects enrolled
    Argentina: 15
    Country: Number of subjects enrolled
    Hong Kong: 1
    Country: Number of subjects enrolled
    India: 28
    Country: Number of subjects enrolled
    Malaysia: 14
    Country: Number of subjects enrolled
    Mexico: 22
    Country: Number of subjects enrolled
    Puerto Rico: 5
    Country: Number of subjects enrolled
    Romania: 22
    Country: Number of subjects enrolled
    Switzerland: 5
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    United States: 293
    Country: Number of subjects enrolled
    Costa Rica: 13
    Worldwide total number of subjects
    1032
    EEA total number of subjects
    588
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    1
    Adults (18-64 years)
    1008
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Of 2584 subjects screened, 1047 subjects were enrolled in the study. Of these 1047 subjects, 1032 subjects were treated with maraviroc.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Maraviroc
    Arm description
    Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
    Arm type
    Experimental

    Investigational medicinal product name
    Maraviroc
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Maraviroc 150 mg twice daily (BID), 600 mg BID, or 300 mg BID; administered orally.

    Number of subjects in period 1
    Maraviroc
    Started
    1032
    treated
    1032
    Safety Analysis Set
    1032
    Completed
    916
    Not completed
    116
         Death
    14
         Insufficient Clinical Response
    22
         Protocol Violation
    1
         Consent withdrawn by subject
    18
         Unspecified
    23
         Adverse Event
    23
         Lost to follow-up
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Maraviroc
    Reporting group description
    Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.

    Reporting group values
    Maraviroc Total
    Number of subjects
    1032 1032
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    45.6 ± 8.6 -
    Gender categorical
    Units: Subjects
        Female
    205 205
        Male
    827 827
    Baseline Overall Viral Load: Absolute Value
    Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) at baseline (original scale). Baseline value calculated as average of screening and baseline values if both values were within 1 log10 difference. Number of subjects contributing to summary statistics at baseline for overall viral load was 979. Viral loads were not available uniformly for all subjects enrolled in study.
    Units: copies/millilitre (mL)
        arithmetic mean (standard deviation)
    117846.1 ± 321426.5 -
    Baseline Viral Load less than (<) 100,000: Absolute Value
    HIV-1 RNA at baseline (original scale). Baseline value calculated as average of screening and baseline values if both values were within 1 log10 difference. Number of subjects contributing to summary statistics at baseline for viral load < 100,000 was 729. Viral loads were not available uniformly for all subjects enrolled in study.
    Units: copies/mL
        arithmetic mean (standard deviation)
    22395.9 ± 25974.4 -
    Baseline Viral Load Gtearter Than or Equal to (>=) 100,000: Absolute Value
    HIV-1 RNA at baseline (original scale). Baseline value calculated as average of screening and baseline values if both values were within 1 log10 difference. Number of subjects contributing to summary statistics at baseline for viral load >= 100,000 was 250. Viral loads were not available uniformly for all subjects enrolled in study.
    Units: copies/mL
        arithmetic mean (standard deviation)
    396179 ± 547142.6 -
    Baseline Overall Viral Load: Absolute Value
    HIV-1 RNA at baseline (original scale). Baseline value calculated as average of screening and baseline values if both values were within 1 log10 difference. Baseline value calculated as average of screening and baseline values if both values were within 1 log10 difference. Number of subjects contributing to summary statistics at baseline for overall viral load was 979. Viral loads were not available uniformly for all subjects enrolled in study.
    Units: copies/mL
        median (full range (min-max))
    25109.5 (39 to 5728492) -
    Baseline Viral Load <100,000: Absolute Value
    HIV-1 RNA at baseline (original scale). Baseline value calculated as average of screening and baseline values if both values were within 1 log10 difference. Number of subjects contributing to summary statistics at baseline for viral load < 100,000 was 729. Viral loads were not available uniformly for all subjects enrolled in study.
    Units: copies/mL
        median (full range (min-max))
    11028.5 (39 to 99643) -
    Baseline Viral Load >=100,000: Absolute Value
    HIV-1 RNA at baseline (original scale). Baseline value calculated as average of screening and baseline values if both values were within 1 log10 difference. Number of subjects contributing to summary statistics at baseline for viral load >= 100,000 was 250. Viral loads were not available uniformly for all subjects enrolled in study.
    Units: copies/mL
        median (full range (min-max))
    234750 (100000 to 5728492) -
    Baseline Overall Viral Load: Log Scale
    HIV-1 RNA at baseline (log10 copies/mL). Baseline value calculated as average of screening and baseline values if both values were within 1 log10 difference. Number of subjects contributing to summary statistic at Baseline was 979. Viral loads were not available uniformly for all subjects enrolled in study.
    Units: log10 copies/mL
        arithmetic mean (standard deviation)
    4.259 ± 1.0182 -
    Baseline Viral Load <100,000: Log Scale
    HIV-1 RNA at baseline (log10 copies/mL). Baseline value calculated as average of screening and baseline values if both values were within 1 log10 difference. Number of subjects contributing to summary statistic at Baseline was 729. Viral loads were not available uniformly for all subjects enrolled in study.
    Units: log10 copies/mL
        arithmetic mean (standard deviation)
    3.859 ± 0.8517 -
    Baseline Viral Load >=100,000: Log Scale
    HIV-1 RNA at baseline (log10 copies/mL). Baseline value calculated as average of screening and baseline values if both values were within 1 log10 difference. Number of subjects contributing to summary statistic at Baseline was 250. Viral loads were not available uniformly for all subjects enrolled in study.
    Units: log10 copies/mL
        arithmetic mean (standard deviation)
    5.423 ± 0.3496 -
    Baseline Overall Viral Load: Log Scale
    HIV-1 RNA at baseline (log10 copies/mL). Baseline value calculated as average of screening and baseline values if both values were within 1 log10 difference. Number ofsubjects contributing to summary statistic at Baseline was 979. Viral loads were not available uniformly for all subjects enrolled in study.
    Units: log10 copies/mL
        median (full range (min-max))
    4.4 (1.591 to 6.758) -
    Baseline Viral Load <100,000: Log Scale
    HIV-1 RNA at baseline (log10 copies/mL). Baseline value calculated as average of screening and baseline values if both values were within 1 log10 difference. Number of subjects contributing to summary statistic at Baseline was 729. Viral loads were not available uniformly for all subjects enrolled in study.
    Units: log10 copies/mL
        median (full range (min-max))
    4.043 (1.591 to 4.998) -
    Baseline Viral Load >=100,000: Log Scale
    HIV-1 RNA at baseline (log10 copies/mL). Baseline value calculated as average of screening and baseline values if both values were within 1 log10 difference. Number of subjects contributing to summary statistic at Baseline was 250. Viral loads were not available uniformly for all subjects enrolled in study.
    Units: log10 copies/mL
        median (full range (min-max))
    5.371 (5 to 6.758) -

    End points

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    End points reporting groups
    Reporting group title
    Maraviroc
    Reporting group description
    Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.

    Primary: Percentage of Subjects With Grade 3 and Grade 4 Adverse Events (AE)

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    End point title
    Percentage of Subjects With Grade 3 and Grade 4 Adverse Events (AE) [1]
    End point description
    AEs as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3 = severe: interrupted usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 = very severe: events that were unacceptable and intolerable or were irreversable or caused imminent danger of death. If same subject had more than 1 occurrence in the same preferred term event category, only the most severe (grade 4) occurrence was taken. Treatment-related = investigator assessment of a reasonable possibility that the investigational product caused or contributed to the AE. Safety analysis set: all subjects who were randomized and received at least one dose of study medication.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 144
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this was an open label, non-randomized, single arm study, only descriptive data was planned to be reported.
    End point values
    Maraviroc
    Number of subjects analysed
    1032
    Units: percentage of subjects
    number (not applicable)
        Grade 3 AE: all causality
    13.2
        Grade 3 AE: treatment related
    2.4
        Grade 4 AE: all causality
    6.3
        Grade 4 AE: treatment related
    1.6
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities

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    End point title
    Percentage of Subjects With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities [2]
    End point description
    Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3, Severe =events that interrupted subjects usual daily activity and traditionally required systemic drug therapy or other treatment. Safety analysis set. N = number of subjects evaluable for laboratory abnormalities (with at least one observation of a laboratory test while on study treatment or during lag time); n = number of subjects with at least one observation of given laboratory test while on study treatment or during lag time.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 144
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this was an open label, non-randomized, single arm study, only descriptive data was planned to be reported.
    End point values
    Maraviroc
    Number of subjects analysed
    1014
    Units: percentage of subjects
    number (not applicable)
        Alanine aminotransferase (ALT) (n=1013)
    2.17
        Aspartate aminotransferase (AST) (n=1013)
    2.07
        Absolute Neutrophil Count (n=1004)
    0.7
        Alkaline Phosphatase (n=1014)
    0.39
        Creatinine (n=1014)
    0.49
        Gamma-glutamyl transpeptidase (GGT) (n=1014)
    4.73
        Hemoglobin (n=1005)
    0.2
        Hyperbilirubinemia (n=1013)
    1.28
        Hyperuricemia (n=1014)
    0.69
        Hypophosphatemia (n=1014)
    0.2
        Lipase (n=409)
    4.4
        Platelets (n=997)
    1.5
        Potassium (hyperkalemia) (n=1014)
    0.1
        Serum Amylase (n=1014)
    4.83
        Sodium (hypernatremia) (n=1014)
    0.1
        Triglycerides (n=1014)
    4.73
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities

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    End point title
    Percentage of Subjects With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities [3]
    End point description
    Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 4, Very Severe = events which were unacceptable and intolerable or were irreversible or caused the subjects to be in imminent danger of death. Safety analysis set. N = number of subjects evaluable for laboratory abnormalities (with at least one observation of a laboratory test while on study treatment or during lag time); n = number of subjects with at least one observation of given laboratory test while on study treatment or during lag time.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 144
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this was an open label, non-randomized, single arm study, only descriptive data was planned to be reported.
    End point values
    Maraviroc
    Number of subjects analysed
    1014
    Units: percentage of subjects
    number (not applicable)
        ALT (n=1013)
    0.79
        AST (n=1013)
    0.39
        Absolute Neutrophil Count (n=1004)
    0.2
        Alkaline Phosphatase (n=1014)
    0
        Creatinine (n=1014)
    0.1
        GGT (n=1014)
    1.48
        Hemoglobin (n=1005)
    0.1
        Hyperbilirubinemia (n=1013)
    0.3
        Hyperuricemia (n=1014)
    0.1
        Hypophosphatemia (n=1014)
    0
        Lipase (n=409)
    1.22
        Platelets (n=997)
    0.3
        Potassium (hyperkalemia) (n=1014)
    0.2
        Serum Amylase (n=1014)
    0.3
        Sodium (hypernatremia) (n=1014)
    0.2
        Triglycerides (n=1014)
    1.97
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses

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    End point title
    Percentage of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses [4]
    End point description
    Treatment-emergent AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C adverse events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 30 days after last dose of study drug. Safety analysis set.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 144
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this was an open label, non-randomized, single arm study, only descriptive data was planned to be reported.
    End point values
    Maraviroc
    Number of subjects analysed
    1032
    Units: percentage of subjects
    number (not applicable)
        AIDS encephalopathy
    0.1
        Bone tuberculosis
    0.1
        Cytomegalovirus infection
    0.2
        Extrapulmonary tuberculosis
    0.1
        Meningitis cryptococcal
    0.1
        Meningitis tuberculous
    0.1
        Mycobacterium avium complex infection
    0.1
        Mycobacterium kansasii infection
    0.1
        Oesophageal candidiasis
    0.6
        Pancreatitis bacterial
    0.1
        Pneumocystis jiroveci pneumonia
    0.1
        Progressive multifocal leukoencephalopathy
    0.1
        Pulmonary tuberculosis
    0.5
        Toxoplasmosis
    0.1
        B-cell lymphoma
    0.1
        Hodgkin’s disease
    0.1
        Kaposi’s sarcoma
    0.2
        Encephalopathy
    0.1
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load

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    End point title
    Percentage of Subjects With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load [5]
    End point description
    Due to the limited data available for this endpoint, a summary of AIDS related infections by baseline viral load is not clinically meaningful.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 144
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this was an open label, non-randomized, single arm study, only descriptive data was planned to be reported.
    End point values
    Maraviroc
    Number of subjects analysed
    0 [6]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [6] - Data not analyzed due to the limited data available for this endpoint.
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts

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    End point title
    Percentage of Subjects With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts [7]
    End point description
    Due to the limited data available for this endpoint, a summary of AIDS related infections by by Baseline/Nadir CD4 Cell Counts is not clinically meaningful.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 144
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this was an open label, non-randomized, single arm study, only descriptive data was planned to be reported.
    End point values
    Maraviroc
    Number of subjects analysed
    0 [8]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [8] - Data not analyzed due to the limited data available for this endpoint.
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy

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    End point title
    Percentage of Subjects With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy [9]
    End point description
    Due to the limited data available for this endpoint, a summary of AIDS related infections by time is not clinically meaningful.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 144
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this was an open label, non-randomized, single arm study, only descriptive data was planned to be reported.
    End point values
    Maraviroc
    Number of subjects analysed
    0 [10]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [10] - Data not analyzed due to the limited data available for this endpoint.
    No statistical analyses for this end point

    Primary: Percentage of Subjects With All Causality Treatment-emergent Adverse (AEs) Events by Gender

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    End point title
    Percentage of Subjects With All Causality Treatment-emergent Adverse (AEs) Events by Gender [11]
    End point description
    Treatment-emergent AEs by gender that occurred up to 30 days after the last dose of study medication. Safety analysis set; n = number of subjects evaluable for adverse events.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 144
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this was an open label, non-randomized, single arm study, only descriptive data was planned to be reported.
    End point values
    Maraviroc
    Number of subjects analysed
    1032
    Units: percentage of subjects
    number (not applicable)
        Male (n=827)
    69.6
        Female (n=205)
    73.7
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Treatment-emergent Adverse Events (AEs) by Race

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    End point title
    Percentage of Subjects With Treatment-emergent Adverse Events (AEs) by Race [12]
    End point description
    Treatment-emergent AEs by race that occurred up to 30 days after the last dose of study medication. Safety analysis set; n = number of subjects evaluable for adverse events.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 144
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this was an open label, non-randomized, single arm study, only descriptive data was planned to be reported.
    End point values
    Maraviroc
    Number of subjects analysed
    1032
    Units: percentage of subjects
    number (not applicable)
        White (n=817)
    68.5
        Black (n=106)
    67.9
        Asian (n=54)
    88.9
        Other Unspecified (n=55)
    85.5
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Treatment-emergent Adverse Events (AEs) by Age

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    End point title
    Percentage of Subjects With Treatment-emergent Adverse Events (AEs) by Age [13]
    End point description
    Treatment-emergent AEs by age that occurred up to 30 days after the last dose of study medication. Safety analysis set; n = number of subjects evaluable for adverse events.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 144
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this was an open label, non-randomized, single arm study, only descriptive data was planned to be reported.
    End point values
    Maraviroc
    Number of subjects analysed
    1032
    Units: percentage of subjects
    number (not applicable)
        <18 years (n=1)
    100
        18 to 44 years (n=515)
    71.7
        45 to 64 years (n=493)
    68.6
        >=65 years (n=23)
    82.6
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status

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    End point title
    Percentage of Subjects With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status [14]
    End point description
    Treatment emergent AEs by hepatis B and hepatitis C serology status that occurred up to 30 days post last dose. Safety analysis set; n = number of subjects evaluable for adverse events. Abbreviations: HBV = hepatitis B virus, HBC = hepatitis C virus.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 144
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this was an open label, non-randomized, single arm study, only descriptive data was planned to be reported.
    End point values
    Maraviroc
    Number of subjects analysed
    1032
    Units: percentage of subjects
    number (not applicable)
        HBV: negative (n=897)
    71.3
        HBV: positive (n=60)
    65
        HBV: missing: (n=75)
    64
        HCV: negative (n=794)
    72.7
        HCV: positive (n=158)
    62.7
        HCV: missing (n=80)
    63.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With ≥0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA)

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    End point title
    Percentage of Subjects With ≥0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA)
    End point description
    Defined as HIV-1 RNA levels < 400 Copies/mL or at least 0.5 Log 10-decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference. Safety analysis set; n = number of subjects contributing to summary statistic at given timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 144
    End point values
    Maraviroc
    Number of subjects analysed
    1032
    Units: percentage of subjects
    number (not applicable)
        Day 2-7 (n=26)
    46.2
        Week 2 (n=226)
    93.8
        Week 4 (n=773)
    93
        Week 8 (n=761)
    93.2
        Week 12 (n=756)
    94
        Week 16 (n=155)
    87.7
        Week 20 (n=131)
    93.1
        Week 24 (n=557)
    91.9
        Week 32 (n=202)
    93.1
        Week 40 (n=227)
    91.2
        Week 48 (n=228)
    89
        Week 60 (n=160)
    90
        Week 72 (n=125)
    88
        Week 84 (n=79)
    84.8
        Week 96 (n=48)
    91.7
        Week 108 (n=18)
    100
        Week 120 (n=9)
    100
        Week 132 (n=4)
    100
        Week 144 (n=1)
    100
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With ≥1.0 log10 Reduction From Baseline in HIV 1 RNA

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    End point title
    Percentage of Subjects With ≥1.0 log10 Reduction From Baseline in HIV 1 RNA
    End point description
    Defined as HIV-1 RNA levels < 400 copies/mL or at least 1.0 Log 10-decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference. Safety analysis set; n = number of subjects contributing to summary statistic at given timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 144
    End point values
    Maraviroc
    Number of subjects analysed
    1032
    Units: percentage of subjects
    number (not applicable)
        Day 2-7 (n=26)
    30.8
        Week 2 (n=226)
    90.3
        Week 4 (n=773)
    90.2
        Week 8 (n=761)
    91.2
        Week 12 (n=756)
    91.3
        Week 16 (n=155)
    82.6
        Week 20 (n=131)
    89.3
        Week 24 (n=557)
    89
        Week 32 (n=202)
    90.1
        Week 40 (n=227)
    87.7
        Week 48 (n=228)
    86.4
        Week 60 (n=160)
    85.6
        Week 72 (n=125)
    83.2
        Week 84 (n=79)
    79.7
        Week 96 (n=48)
    85.4
        Week 108 (n=18)
    100
        Week 120 (n=9)
    100
        Week 132 (n=4)
    100
        Week 144 (n=1)
    100
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL

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    End point title
    Percentage of Subjects With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL
    End point description
    Limit of quantification defined as <400 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference. Safety analysis set; n = number of subjects contributing to summary statistic at given timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 144
    End point values
    Maraviroc
    Number of subjects analysed
    1032
    Units: percentage of subjects
    number (not applicable)
        Baseline (n=979)
    6.7
        Day 2-7 (n=26)
    3.8
        Week 2 (n=226)
    58.8
        Week 4 (n=773)
    72.7
        Week 8 (n=761)
    78.8
        Week 12 (n=756)
    82.5
        Week 16 (n=155)
    75.5
        Week 20 (n=131)
    83.2
        Week 24 (n=557)
    84.4
        Week 32 (n=202)
    83.7
        Week 40 (n=227)
    81.1
        Week 48 (n=228)
    80.7
        Week 60 (n=160)
    78.1
        Week 72 (n=125)
    72.8
        Week 84 (n=79)
    74.7
        Week 96 (n=48)
    75
        Week 108 (n=18)
    88.9
        Week 120 (n=9)
    77.8
        Week 132 (n=4)
    100
        Week 144 (n=1)
    100
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL

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    End point title
    Percentage of Subjects With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL
    End point description
    Limit of quantification defined as <50 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference. Safety analysis set; n = number of subjects contributing to summary statistic at given timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 144
    End point values
    Maraviroc
    Number of subjects analysed
    1032
    Units: percentage of subjects
    number (not applicable)
        Baseline (n=979)
    1.7
        Day 2-7 (n=26)
    0
        Week 2 (n=226)
    19.9
        Week 4 (n=773)
    30.1
        Week 8 (n=761)
    43.1
        Week 12 (n=756)
    45.8
        Week 16 (n=155)
    37.4
        Week 20 (n=131)
    42.7
        Week 24 (n=557)
    55.8
        Week 32 (n=202)
    57.4
        Week 40 (n=227)
    54.6
        Week 48 (n=228)
    54.8
        Week 60 (n=160)
    51.9
        Week 72 (n=125)
    49.6
        Week 84 (n=79)
    55.7
        Week 96 (n=48)
    54.2
        Week 108 (n=18)
    77.8
        Week 120 (n=9)
    44.4
        Week 132 (n=4)
    75
        Week 144 (n=1)
    100
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Cell Count

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    End point title
    Change From Baseline in CD4 Cell Count
    End point description
    Change from baseline in cluster of differentiation 4 helper T cells (CD4) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value. Safety analysis set; n = number of subjects contributing to summary statistic at given timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 144
    End point values
    Maraviroc
    Number of subjects analysed
    1032
    Units: cells per microliter (cells/mcL)
    arithmetic mean (standard deviation)
        Day 2-7 (n=6)
    28.5 ± 76.18
        Week 2 (n=213)
    49.7 ± 93.15
        Week 4 (n=762)
    68.9 ± 124.31
        Week 8 (n=739)
    94.5 ± 122.94
        Week 12 (n=738)
    95.7 ± 124.42
        Week 16 (n=149)
    85.9 ± 124.37
        Week 20 (n=130)
    106.6 ± 112.26
        Week 24 (n=552)
    127.8 ± 139.42
        Week 32 (n=197)
    124.1 ± 150.44
        Week 40 (n=232)
    129.2 ± 144.31
        Week 48 (n=222)
    140.5 ± 154.46
        Week 60 (n=161)
    134 ± 151.52
        Week 72 (n=124)
    147 ± 160.92
        Week 84 (n=72)
    141.1 ± 147.55
        Week 96 (n=50)
    160.3 ± 160.78
        Week 108 (n=19)
    242.9 ± 167.06
        Week 120 (n=8)
    117.9 ± 203.49
        Week 132 (n=4)
    179 ± 109.94
        Week 144 (n=1)
    93 ± 0
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Cell Count Percent

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    End point title
    Change From Baseline in CD4 Cell Count Percent
    End point description
    Change from baseline in CD4 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value. Safety analysis set; n = number of subjects contributing to summary statistic at given timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 144
    End point values
    Maraviroc
    Number of subjects analysed
    1032
    Units: percentage of lymphocytes
    arithmetic mean (standard deviation)
        Days 2-7 (n=6)
    -1.3 ± 1.56
        Week 2 (n=206)
    1.8 ± 3.79
        Week 4 (n=733)
    1.6 ± 4.84
        Week 8 (n=722)
    1.4 ± 6.12
        Week 12 (n=708)
    1.6 ± 5.45
        Week 16 (n=141)
    1.9 ± 4.63
        Week 20 (n=125)
    2.2 ± 6.17
        Week 24 (n=531)
    2.8 ± 4.55
        Week 32 (n=191)
    3.2 ± 5.38
        Week 40 (n=218)
    3.7 ± 4.97
        Week 48 (n=210)
    3.5 ± 5.87
        Week 60 (n=148)
    4.5 ± 6.1
        Week 72 (n=116)
    5 ± 6.33
        Week 84 (n=64)
    5.7 ± 6.73
        Week 96 (n=41)
    3.9 ± 6.36
        Week 108 (n=19)
    6.3 ± 6.86
        Week 120 (n=7)
    5.7 ± 9.07
        Week 132 (n=4)
    8.5 ± 8.35
        Week 144 (n=1)
    1 ± 0
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD8 Cell Count

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    End point title
    Change From Baseline in CD8 Cell Count
    End point description
    Change from baseline in cluster of differentiation 8 suppressor T cells (CD8) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value. Safety analysis set; n = number of subjects contributing to summary statistic at given timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 144
    End point values
    Maraviroc
    Number of subjects analysed
    1032
    Units: cells/mcL
    arithmetic mean (standard deviation)
        Day 2-7 (n=6)
    268.5 ± 262.5
        Week 2 (n=201)
    78.2 ± 343.85
        Week 4 (n=701)
    205.6 ± 509.7
        Week 8 (n=692)
    345.6 ± 599.98
        Week 12 (n=696)
    309.4 ± 578.91
        Week 16 (n=129)
    259.6 ± 430.78
        Week 20 (n=119)
    325.2 ± 621.46
        Week 24 (n=523)
    251.3 ± 498.85
        Week 32 (n=185)
    185.2 ± 484.74
        Week 40 (n=222)
    160.9 ± 471.99
        Week 48 (n=214)
    153.2 ± 464.73
        Week 60 (n=157)
    76.9 ± 467.64
        Week 72 (n=120)
    68.7 ± 502.73
        Week 84 (n=70)
    -11.6 ± 548.85
        Week 96 (n=45)
    56.6 ± 403.1
        Week 108 (n=19)
    147.5 ± 600.55
        Week 120 (n=8)
    -135.1 ± 517.02
        Week 132 (n=4)
    -363.3 ± 882.3
        Week 144 (n=1)
    642 ± 0
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD8 Cell Count Percent

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    End point title
    Change From Baseline in CD8 Cell Count Percent
    End point description
    Change from baseline in CD8 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value. Safety analysis set; n = number of subjects contributing to summary statistic at given timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 144
    End point values
    Maraviroc
    Number of subjects analysed
    1032
    Units: percentage of lymphocytes
    arithmetic mean (standard deviation)
        Day 2-7 (n=6)
    3 ± 3.42
        Week 2 (n=197)
    -1.5 ± 7.68
        Week 4 (n=689)
    -0.3 ± 8.08
        Week 8 (n=683)
    0.4 ± 9.62
        Week 12 (n=675)
    -0.9 ± 9.95
        Week 16 (n=125)
    0.7 ± 8.66
        Week 20 (n=115)
    -0.7 ± 10.08
        Week 24 (n=510)
    -3.2 ± 8.92
        Week 32 (n=184)
    -4 ± 9.09
        Week 40 (n=215)
    -4.5 ± 8.9
        Week 48 (n=202)
    -5.1 ± 10.63
        Week 60 (n=146)
    -5 ± 11.9
        Week 72 (n=113)
    -6.2 ± 9.87
        Week 84 (n=64)
    -8.2 ± 15.52
        Week 96 (n=40)
    -9.5 ± 10.18
        Week 108 (n=19)
    -14.5 ± 9.99
        Week 120 (n=6)
    -14.5 ± 13.41
        Week 132 (n=4)
    -16.8 ± 12.89
        Week 144 (n=1)
    -2 ± 0
    No statistical analyses for this end point

    Secondary: Median Time to Virologic Failure

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    End point title
    Median Time to Virologic Failure
    End point description
    Computed as time from the first dose of study medication to the loss of virologic response. Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ. Safety analysis set. For the calculation of the time to virologic failure, any visits with no data were excluded. Subjects who were not virologic failures were censored at the last available observation.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Week 144
    End point values
    Maraviroc
    Number of subjects analysed
    192 [15]
    Units: days
        median (inter-quartile range (Q1-Q3))
    86.5 (58 to 169)
    Attachments
    Stat Analysis Median Time to Virologic Failure
    Notes
    [15] - N = number of subjects with virologic failure.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Changes in HIV-1 RNA Level in Subjects Meeting the Definition of Virologic Failure

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    End point title
    Percentage of Subjects With Changes in HIV-1 RNA Level in Subjects Meeting the Definition of Virologic Failure
    End point description
    Reasons for virologic failure: A) failure to achieve a reduction in HIV-1 RNA>=0.5 log10 copies/ml from baseline (BL) by second viral load determination (unless below level of quantification [LOQ]); B) >=0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from BL >0.5 log10 copies/ml ; C) HIV-1 RNA >1000 copies/ml after having achieved an HIV-1 RNA below LOQ. Safety analysis set.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 144
    End point values
    Maraviroc
    Number of subjects analysed
    192 [16]
    Units: percentage of subjects
    number (not applicable)
        Reduction in HIV-1 RNA<0.5 log10 copies/ml
    43.75
        >=0.5 log10 increase from nadir in HIV-1 RNA
    31.77
        HIV-1 RNA >1000 copies/ml
    18.75
        Reduction <0.5 log10 + HIV-1 RNA >1000 copies/ml
    3.13
        >=0.5 log10 increase from nadir + HIV-1 RNA >1000
    2.6
    Notes
    [16] - N = number of subjects with virologic failure.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Change in Chemokine Co-receptor Tropism From Screening to Time of Virologic Failure

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    End point title
    Percentage of Subjects With Change in Chemokine Co-receptor Tropism From Screening to Time of Virologic Failure
    End point description
    Tropism status (CCR5 [R5], Dual Mixed [DM], or Non-reportable [NR]) at Screening [Scr] and R5, CXCR4 [X4], DM, or NR) at time of virologic failure (V fail). Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥0.5 log10 copies/mL by second viral load determination (unless viral load was below lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ. Safety analysis set. Abbreviations: Scr = screening, R5 = CCR5 tropic HIV-1, X4=CXCR4 tropic HIV-1, DM = dual mixed, NR = non-reportable, Missing = subjects with VF who did not have tropism result within specified screening period (Scr missing: -42 days to Day 0) or at the time of VF. 1 subject with NR was erroneously enrolled in the study.
    End point type
    Secondary
    End point timeframe
    Screening up to Week 144
    End point values
    Maraviroc
    Number of subjects analysed
    192 [17]
    Units: percentage of subjects
    number (not applicable)
        Scr: Missing; V fail: R5
    5.73
        Scr: Missing; V fail: X4
    0.52
        Scr: Missing; V fail: DM
    1.04
        Scr: Missing; V fail: NR
    7.29
        Scr: Missing; V fail: Missing
    1.56
        Scr: NR; V fail: R5
    0.52
        Scr: R5; V fail: R5
    31.25
        Scr: R5; V fail: X4
    4.17
        Scr: R5; V fail: DM
    18.75
        Scr: R5; V fail: NR
    22.92
        Scr: R5; V fail: Missing
    6.25
    Notes
    [17] - N = subjects with virologic failure.
    No statistical analyses for this end point

    Secondary: Number of Subjects With Emergence of Resistance to Maraviroc as Defined by Genotypic Changes in the V3 Loop of Glycoprotein 120 (gp 120)

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    End point title
    Number of Subjects With Emergence of Resistance to Maraviroc as Defined by Genotypic Changes in the V3 Loop of Glycoprotein 120 (gp 120)
    End point description
    Virus from subjects who experienced virologic failure was analyzed for resistance to maraviroc. Resistance testing was performed on archived samples of subjects which were available pre-treatment at time of virologic failure. For subjects who met definition of virologic failure during the trial, the sequencing of the V3 loop of HIV-1 viral envelope gp 120 was evaluated to identify any amino acid changes concomitant with decreased susceptibility to maraviroc. Emergence of resistance was observed least frequently in virus from subjects who failed therapy with maraviroc-susceptible R5 virus, consistent with possibility that they failed because of poor adherence. Here "99999" in results section signifies data not available (NA) due to lack of any distinct mutational pattern for resistance in analyzed subjects.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 144
    End point values
    Maraviroc
    Number of subjects analysed
    13 [18]
    Units: Subjects
    99999
    Notes
    [18] - Data not analysed due to lack of distinct mutational pattern for resistance in analysed subjects.
    No statistical analyses for this end point

    Secondary: Number of Subjects With Reduced Maraviroc Susceptibility as Defined by Change From Baseline to Time of Virologic Failure in Inhibitory Concentration of 50% (IC 50) and Presence of Plateau

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    End point title
    Number of Subjects With Reduced Maraviroc Susceptibility as Defined by Change From Baseline to Time of Virologic Failure in Inhibitory Concentration of 50% (IC 50) and Presence of Plateau
    End point description
    Resistance to maravroc in viruses from subjects failing therapy with R5 virus was investigated using the in vitro phenotypic (drug susceptibility) assay. The number of subjects who failed with R5 virus were assessed successfully for maraviroc susceptibility at Baseline and Last on-treatment (Week 144). Samples were analyzed for change from Baseline to time of virologic failure in IC 50 and presence of plateau. A maximal percent inhibition (MPI) <95% established as a plateau in inhibition at high concentrations of maraviroc was used to identify viruses which had reduced phenotypic susceptibility to maraviroc.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 144
    End point values
    Maraviroc
    Number of subjects analysed
    26 [19]
    Units: Subjects
    14
    Notes
    [19] - N= subjects who were assessed for maraviroc susceptibility
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events were reported from time of first dose of study drug up to 30 days after last dose of study drug.
    Adverse event reporting additional description
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    MARAVIROC
    Reporting group description
    Maraviroc 150 mg twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.

    Serious adverse events
    MARAVIROC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    139 / 1032 (13.47%)
         number of deaths (all causes)
    16
         number of deaths resulting from adverse events
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Hypertension
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Coronary artery bypass
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anal cancer
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Anal squamous cell carcinoma
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Penile squamous cell carcinoma
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Carcinoma in situ of penis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal cancer
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastric cancer
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Immune system disorders
    Immune reconstitution inflammatory syndrome
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    7 / 1032 (0.68%)
         occurrences causally related to treatment / all
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    Chills
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gait disturbance
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Drug interaction
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyperthermia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    10 / 1032 (0.97%)
         occurrences causally related to treatment / all
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Psychiatric disorders
    Anxiety disorder
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Completed suicide
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Homicidal ideation
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hallucination, auditory
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Depression
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Suicide attempt
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Joint injury
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post lumbar puncture syndrome
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Blood glucose increased
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Clostridium test positive
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Weight decreased
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Myocardial infarction
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cough
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    5 / 1032 (0.48%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Hypoxia
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 1032 (0.48%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Brain oedema
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Disturbance in attention
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Convulsion
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Visual impairment
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Vitreous floaters
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Anogenital dysplasia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Anal fissure
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    7 / 1032 (0.68%)
         occurrences causally related to treatment / all
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal polyp
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    1 / 1
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure acute
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Urinary bladder polyp
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Hepatobiliary disorders
    Hepatic failure
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Bile duct stone
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatocellular injury
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Hepatitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatitis cholestatic
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatotoxicity
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypertransaminasaemia
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Diabetic foot
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psoriasis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lichenoid keratosis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Stevens-Johnson syndrome
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rash
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Arthralgia
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Polyarthritis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bone tuberculosis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    AIDS dementia complex
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchitis fungal
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dengue fever
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dysentery
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dermo-hypodermitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Extradural abscess
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Erysipelas
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ear infection
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatitis B
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Leptospirosis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mastoiditis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mycobacterium avium complex infection
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Meningitis cryptococcal
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis bacterial
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mycobacterium kansasii infection
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Pseudomonas infection
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia legionella
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection bacterial
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sinusitis
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Meningitis tuberculous
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pneumonia
         subjects affected / exposed
    11 / 1032 (1.07%)
         occurrences causally related to treatment / all
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    HIV infection
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Septic shock
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Sepsis
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    MARAVIROC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    700 / 1032 (67.83%)
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Ankle fracture
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Arthropod bite
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Bone fissure
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Clavicle fracture
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Contusion
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    4
    Fall
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Excoriation
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Epicondylitis
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Foot fracture
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Foreign body in eye
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Joint injury
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Head injury
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Ligament rupture
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Laceration
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Ligament sprain
         subjects affected / exposed
    5 / 1032 (0.48%)
         occurrences all number
    5
    Limb injury
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Muscle strain
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Periorbital haematoma
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Overdose
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Post procedural haematoma
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Radius fracture
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Skeletal injury
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Sunburn
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Thermal burn
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Upper limb fracture
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    13 / 1032 (1.26%)
         occurrences all number
    18
    Amylase increased
         subjects affected / exposed
    11 / 1032 (1.07%)
         occurrences all number
    15
    Aspartate aminotransferase abnormal
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    9 / 1032 (0.87%)
         occurrences all number
    9
    Blood creatine increased
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Blood cholesterol increased
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Blood alkaline phosphatase
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    8 / 1032 (0.78%)
         occurrences all number
    8
    Blood creatinine increased
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    4
    Blood glucose abnormal
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Blood glucose increased
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    4
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Blood iron decreased
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Blood phosphorus decreased
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    2
    Blood pressure increased
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Blood sodium increased
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Blood triglycerides increased
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    7
    Blood uric acid increased
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    6
    Blood urine present
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Cardiac function test abnormal
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Body temperature increased
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Cardiac murmur
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Eosinophil count increased
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Carotid bruit
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    12 / 1032 (1.16%)
         occurrences all number
    15
    Glycosylated haemoglobin increased
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Helicobacter test positive
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Haemoglobin decreased
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Hepatic enzyme increased
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Hepatitis B DNA increased
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hepatitis B antibody positive
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hepatitis B surface antigen positive
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Hepatitis B virus test positive
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Human papilloma virus test positive
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Lipase increased
         subjects affected / exposed
    7 / 1032 (0.68%)
         occurrences all number
    7
    Liver function test abnormal
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Low density lipoprotein increased
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Lymph node palpable
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    3
    Murphy's sign positive
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Occult blood positive
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Prostatic specific antigen increased
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Platelet count decreased
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Physical examination
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Urine output decreased
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Treponema test positive
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Transaminases increased
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    6
    Waist circumference increased
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Weight decreased
         subjects affected / exposed
    12 / 1032 (1.16%)
         occurrences all number
    13
    Weight increased
         subjects affected / exposed
    11 / 1032 (1.07%)
         occurrences all number
    12
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Cardiac failure congestive
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Cyanosis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Extrasystoles
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Left atrial dilatation
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hyperdynamic left ventricle
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Pericardial effusion
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Palpitations
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Sinus bradycardia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Tachycardia
         subjects affected / exposed
    5 / 1032 (0.48%)
         occurrences all number
    5
    Congenital, familial and genetic disorders
    Preauricular cyst
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Dysmorphism
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Accessory spleen
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Anaemia
         subjects affected / exposed
    18 / 1032 (1.74%)
         occurrences all number
    19
    Eosinophilia
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Bone marrow failure
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Leukocytosis
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Leukopenia
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Lymphadenopathy
         subjects affected / exposed
    18 / 1032 (1.74%)
         occurrences all number
    19
    Microcytic anaemia
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Neutropenia
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Microcytosis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Polycythaemia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Splenomegaly
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Thrombocytopenia
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Amnesia
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    4
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Ataxia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Aphasia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Central nervous system lesion
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    26 / 1032 (2.52%)
         occurrences all number
    27
    Decreased vibratory sense
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Cerebral atrophy
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Epilepsy
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Dysarthria
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Dysaesthesia
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Headache
         subjects affected / exposed
    66 / 1032 (6.40%)
         occurrences all number
    70
    Hyperaesthesia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hypersomnia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hypoaesthesia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    2
    Lethargy
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Memory impairment
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Loss of consciousness
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Migraine
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Neuralgia
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Nerve root compression
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Muscle contractions involuntary
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Neuropathy peripheral
         subjects affected / exposed
    14 / 1032 (1.36%)
         occurrences all number
    14
    Paraesthesia
         subjects affected / exposed
    7 / 1032 (0.68%)
         occurrences all number
    7
    Radiculopathy
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Presyncope
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Sensory disturbance
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Sciatica
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    6
    Serotonin syndrome
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Sleep phase rhythm disturbance
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Somnolence
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Tension headache
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Syncope
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    VIIth nerve paralysis
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Eye disorders
    Blepharitis
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Blindness unilateral
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Cataract
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Conjunctivitis allergic
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Dry eye
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Exophthalmos
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Eye swelling
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Eye irritation
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Glaucoma
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Foreign body sensation in eyes
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Metamorphopsia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Ocular icterus
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Punctate keratitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Pupils unequal
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Uveitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Vision blurred
         subjects affected / exposed
    7 / 1032 (0.68%)
         occurrences all number
    7
    Visual impairment
         subjects affected / exposed
    5 / 1032 (0.48%)
         occurrences all number
    5
    Visual acuity reduced
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Vitreous floaters
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Vitreous detachment
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    4
    Ear pain
         subjects affected / exposed
    7 / 1032 (0.68%)
         occurrences all number
    8
    Cerumen impaction
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Tympanic membrane hyperaemia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Vertigo
         subjects affected / exposed
    12 / 1032 (1.16%)
         occurrences all number
    15
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Abdominal pain
         subjects affected / exposed
    20 / 1032 (1.94%)
         occurrences all number
    23
    Abdominal distension
         subjects affected / exposed
    16 / 1032 (1.55%)
         occurrences all number
    16
    Abdominal pain lower
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Abdominal pain upper
         subjects affected / exposed
    14 / 1032 (1.36%)
         occurrences all number
    19
    Anal fistula
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Abdominal tenderness
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Anal polyp
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Anogenital dysplasia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Anal ulcer
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Anorectal discomfort
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Anorectal disorder
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    4
    Aphthous stomatitis
         subjects affected / exposed
    5 / 1032 (0.48%)
         occurrences all number
    5
    Cheilitis
         subjects affected / exposed
    5 / 1032 (0.48%)
         occurrences all number
    5
    Colitis
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Colitis ulcerative
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Defaecation urgency
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    35 / 1032 (3.39%)
         occurrences all number
    35
    Dental caries
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Diarrhoea haemorrhagic
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    93 / 1032 (9.01%)
         occurrences all number
    109
    Dry mouth
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    6
    Dyspepsia
         subjects affected / exposed
    13 / 1032 (1.26%)
         occurrences all number
    13
    Dysphagia
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    7
    Eructation
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Faecal incontinence
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Faeces soft
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Flatulence
         subjects affected / exposed
    10 / 1032 (0.97%)
         occurrences all number
    10
    Food poisoning
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Functional gastrointestinal disorder
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Gastritis
         subjects affected / exposed
    10 / 1032 (0.97%)
         occurrences all number
    10
    Gastric disorder
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Gastrointestinal disorder
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    4
    Gastrooesophageal reflux disease
         subjects affected / exposed
    9 / 1032 (0.87%)
         occurrences all number
    10
    Gastrointestinal pain
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Glossitis
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Haematochezia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Haemorrhoids
         subjects affected / exposed
    12 / 1032 (1.16%)
         occurrences all number
    15
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Haemorrhoids thrombosed
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hyperchlorhydria
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hypoaesthesia oral
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Inguinal hernia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Intestinal obstruction
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Large intestine polyp
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Mouth ulceration
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Odynophagia
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Nausea
         subjects affected / exposed
    60 / 1032 (5.81%)
         occurrences all number
    67
    Oesophagitis
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Oral discomfort
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Oral disorder
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Oral lichen planus
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Painful defaecation
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    3
    Paraesthesia oral
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Parotid gland enlargement
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Proctalgia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Rectal haemorrhage
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    6
    Tongue discolouration
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    2
    Salivary gland cyst
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Tongue disorder
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Toothache
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Tongue ulceration
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Umbilical hernia
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Uvulitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    34 / 1032 (3.29%)
         occurrences all number
    41
    Renal and urinary disorders
    Bladder disorder
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Calculus bladder
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Calculus ureteric
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Dysuria
         subjects affected / exposed
    9 / 1032 (0.87%)
         occurrences all number
    10
    Chromaturia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Haematuria
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    5
    Microalbuminuria
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Micturition disorder
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Micturition urgency
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Nephritis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Nephroangiosclerosis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Nephrolithiasis
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Nephropathy
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Polyuria
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Pollakiuria
         subjects affected / exposed
    5 / 1032 (0.48%)
         occurrences all number
    6
    Nocturia
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Renal cyst
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Renal failure
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    4
    Renal impairment
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Renal failure acute
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Ureteral disorder
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Renal pain
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Urinary hesitation
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Urinary incontinence
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Urinary tract disorder
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    7
    Actinic keratosis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    2
    Acne
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    4
    Dandruff
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    3
    Dermatitis
         subjects affected / exposed
    8 / 1032 (0.78%)
         occurrences all number
    8
    Dermal cyst
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Drug eruption
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Dermatosis
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Dermatitis contact
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Dermatitis acneiform
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Eosinophilic pustular folliculitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Eczema
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    5
    Erythema
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    4
    Dry skin
         subjects affected / exposed
    9 / 1032 (0.87%)
         occurrences all number
    9
    Facial wasting
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hand dermatitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Erythema multiforme
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Lichen planus
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Intertrigo
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Ingrowing nail
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hyperhidrosis
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    6
    Lipoatrophy
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Lipohypertrophy
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Lipodystrophy acquired
         subjects affected / exposed
    7 / 1032 (0.68%)
         occurrences all number
    7
    Papule
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Onychoclasis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Night sweats
         subjects affected / exposed
    7 / 1032 (0.68%)
         occurrences all number
    7
    Nail ridging
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Penile ulceration
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Polymorphic light eruption
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Prurigo
         subjects affected / exposed
    8 / 1032 (0.78%)
         occurrences all number
    12
    Psoriasis
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    4
    Pruritus
         subjects affected / exposed
    22 / 1032 (2.13%)
         occurrences all number
    25
    Purpura
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Rash maculo-papular
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Rash macular
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Rash erythematous
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    2
    Rash
         subjects affected / exposed
    45 / 1032 (4.36%)
         occurrences all number
    47
    Rash papular
         subjects affected / exposed
    5 / 1032 (0.48%)
         occurrences all number
    5
    Rash pruritic
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Rash vesicular
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Seborrhoea
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Seborrhoeic dermatitis
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    7
    Skin exfoliation
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Skin fibrosis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Skin fragility
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Skin haemorrhage
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Skin irritation
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Skin induration
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Skin lesion
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    8
    Skin mass
         subjects affected / exposed
    10 / 1032 (0.97%)
         occurrences all number
    10
    Skin reaction
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Skin ulcer
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Urticaria
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Swelling face
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    34 / 1032 (3.29%)
         occurrences all number
    34
    Arthritis
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    5
    Bone disorder
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    45 / 1032 (4.36%)
         occurrences all number
    51
    Arthropathy
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Bone pain
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Coccydynia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Bursitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Bursa disorder
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Flank pain
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Enthesopathy
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Costochondritis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Gouty arthritis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Groin pain
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hypercreatinaemia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Intervertebral disc protrusion
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Joint stiffness
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Joint range of motion decreased
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Joint swelling
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Muscle atrophy
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Limb discomfort
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Muscle contracture
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Muscle spasms
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    6
    Musculoskeletal chest pain
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Musculoskeletal pain
         subjects affected / exposed
    11 / 1032 (1.07%)
         occurrences all number
    11
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    20 / 1032 (1.94%)
         occurrences all number
    21
    Neck pain
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    6
    Osteitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Osteoarthritis
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Osteopenia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Osteonecrosis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    20 / 1032 (1.94%)
         occurrences all number
    24
    Polyarthritis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Plantar fasciitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Rotator cuff syndrome
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Spinal pain
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Tendon pain
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Synovial cyst
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    2
    Tendonitis
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    4
    Tenosynovitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Torticollis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Endocrine disorders
    Goitre
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Hypogonadism
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hypothyroidism
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Cell death
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Decreased appetite
         subjects affected / exposed
    9 / 1032 (0.87%)
         occurrences all number
    11
    Dehydration
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Diabetes mellitus
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Dyslipidaemia
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Hyperamylasaemia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Gout
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Folate deficiency
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hypercalcaemia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hypercholesterolaemia
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    4
    Hyperferritinaemia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    5
    Hyperkalaemia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    25 / 1032 (2.42%)
         occurrences all number
    34
    Hyperlipidaemia
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    7
    Hypocalcaemia
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Hyperuricaemia
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Hypocholesterolaemia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hypoglycaemia
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Hypokalaemia
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    6
    Impaired fasting glucose
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Hypovolaemia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Metabolic syndrome
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Malnutrition
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    3
    Increased appetite
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Selenium deficiency
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Vitamin D deficiency
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Vitamin C deficiency
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Zinc deficiency
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Infections and infestations
    Abscess
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Abscess limb
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Acarodermatitis
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Acute hepatitis C
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Anal abscess
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Amoebic dysentery
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    2
    Acute sinusitis
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Anal fungal infection
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Anorectal human papilloma virus infection
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Body tinea
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Bronchiolitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    67 / 1032 (6.49%)
         occurrences all number
    79
    Bronchitis bacterial
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Candida infection
         subjects affected / exposed
    5 / 1032 (0.48%)
         occurrences all number
    5
    Cellulitis
         subjects affected / exposed
    8 / 1032 (0.78%)
         occurrences all number
    8
    Chronic hepatitis C
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Chronic sinusitis
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    5
    Conjunctivitis
         subjects affected / exposed
    10 / 1032 (0.97%)
         occurrences all number
    10
    Conjunctivitis viral
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Cystitis
         subjects affected / exposed
    5 / 1032 (0.48%)
         occurrences all number
    5
    Cytomegalovirus infection
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Diverticulitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Dermo-hypodermitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Ear infection
         subjects affected / exposed
    5 / 1032 (0.48%)
         occurrences all number
    5
    Extrapulmonary tuberculosis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Eye infection
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Fungal infection
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Folliculitis
         subjects affected / exposed
    5 / 1032 (0.48%)
         occurrences all number
    5
    Fungal skin infection
         subjects affected / exposed
    5 / 1032 (0.48%)
         occurrences all number
    5
    Furuncle
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Gastroenteritis viral
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Gastroenteritis
         subjects affected / exposed
    17 / 1032 (1.65%)
         occurrences all number
    17
    Gastrointestinal infection
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    4
    Gastrointestinal viral infection
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Genital abscess
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Genital herpes
         subjects affected / exposed
    11 / 1032 (1.07%)
         occurrences all number
    13
    Genital herpes simplex
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Genital infection fungal
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Genitourinary chlamydia infection
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Gonorrhoea
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Gingivitis
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    6
    Helicobacter gastritis
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Haemophilus infection
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hepatitis A
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hepatitis B
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Hepatitis C
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    4
    Herpes simplex
         subjects affected / exposed
    10 / 1032 (0.97%)
         occurrences all number
    11
    Herpes virus infection
         subjects affected / exposed
    10 / 1032 (0.97%)
         occurrences all number
    10
    Herpes zoster
         subjects affected / exposed
    18 / 1032 (1.74%)
         occurrences all number
    19
    Hordeolum
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Impetigo
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Infection
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Infected bites
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Infestation
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Laryngitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    29 / 1032 (2.81%)
         occurrences all number
    34
    Localised infection
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Lower respiratory tract infection
         subjects affected / exposed
    5 / 1032 (0.48%)
         occurrences all number
    5
    Mastitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Lymphangitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Mastoiditis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Meningitis aseptic
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Molluscum contagiosum
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Mycotic corneal ulcer
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    39 / 1032 (3.78%)
         occurrences all number
    43
    Oesophageal candidiasis
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    7
    Onychomycosis
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    9
    Oral candidiasis
         subjects affected / exposed
    28 / 1032 (2.71%)
         occurrences all number
    41
    Oral fungal infection
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Oral herpes
         subjects affected / exposed
    17 / 1032 (1.65%)
         occurrences all number
    18
    Oral hairy leukoplakia
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Oral infection
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Otitis externa
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Orchitis
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Otitis media
         subjects affected / exposed
    7 / 1032 (0.68%)
         occurrences all number
    8
    Otitis media acute
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Paronychia
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Periodontitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    22 / 1032 (2.13%)
         occurrences all number
    25
    Pneumococcal infection
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    7
    Progressive multifocal leukoencephalopathy
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Prostatitis Escherichia coli
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Pulmonary tuberculosis
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Purulent discharge
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Pyelonephritis
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Pyuria
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Rash pustular
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    5 / 1032 (0.48%)
         occurrences all number
    6
    Respiratory tract infection viral
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Rhinitis
         subjects affected / exposed
    13 / 1032 (1.26%)
         occurrences all number
    13
    Scrotal infection
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Secondary syphilis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Sepsis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Shigella infection
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    28 / 1032 (2.71%)
         occurrences all number
    28
    Skin infection
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Staphylococcal skin infection
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Staphylococcal infection
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Syphilis
         subjects affected / exposed
    7 / 1032 (0.68%)
         occurrences all number
    7
    Tinea infection
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    4
    Tinea cruris
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Tinea pedis
         subjects affected / exposed
    5 / 1032 (0.48%)
         occurrences all number
    5
    Tinea versicolour
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Tooth abscess
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Tooth infection
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    4
    Toxoplasmosis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Tracheitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    41 / 1032 (3.97%)
         occurrences all number
    62
    Urethritis
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Urethritis gonococcal
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    17 / 1032 (1.65%)
         occurrences all number
    19
    Urinary tract infection enterococcal
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Viral infection
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    7
    Urinary tract infection fungal
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Viral pharyngitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Viral sinusitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    4
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Wound infection
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Vascular disorders
    Aortic stenosis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Flushing
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Haematoma
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Haemorrhage
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hot flush
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Hypertension
         subjects affected / exposed
    22 / 1032 (2.13%)
         occurrences all number
    23
    Hypertensive crisis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Orthostatic hypotension
         subjects affected / exposed
    5 / 1032 (0.48%)
         occurrences all number
    5
    Hypotension
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Pallor
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Peripheral venous disease
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Phlebitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Thrombophlebitis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Venoocclusive disease
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Venous thrombosis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Surgical and medical procedures
    Circumcision
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Papilloma excision
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Dental implantation
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Prophylaxis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Tooth extraction
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    6 / 1032 (0.58%)
         occurrences all number
    6
    Basal cell carcinoma
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    2
    Bowen's disease
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Haemangioma
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Kaposi's sarcoma
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Lipoma
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Oral papilloma
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    6
    Prostatic adenoma
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Penile wart
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Skin papilloma
         subjects affected / exposed
    9 / 1032 (0.87%)
         occurrences all number
    11
    Seborrhoeic keratosis
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Rectal cancer
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Thyroid neoplasm
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Testicular neoplasm
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Uterine leiomyoma
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Allergy to arthropod bite
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Food allergy
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Seasonal allergy
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Immune reconstitution inflammatory syndrome
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Hypersensitivity
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    3
    Social circumstances
    Alcohol use
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Asthenia
         subjects affected / exposed
    22 / 1032 (2.13%)
         occurrences all number
    23
    Chest discomfort
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Chest pain
         subjects affected / exposed
    10 / 1032 (0.97%)
         occurrences all number
    10
    Chills
         subjects affected / exposed
    5 / 1032 (0.48%)
         occurrences all number
    5
    Crepitations
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Facial pain
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Fat tissue increased
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    24 / 1032 (2.33%)
         occurrences all number
    29
    Feeling hot
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Feeling jittery
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Injection site nodule
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Influenza like illness
         subjects affected / exposed
    14 / 1032 (1.36%)
         occurrences all number
    14
    Injection site swelling
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Injection site reaction
         subjects affected / exposed
    8 / 1032 (0.78%)
         occurrences all number
    8
    Local swelling
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Malaise
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    4
    Mucosal inflammation
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Necrosis
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Nodule
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    4
    Oedema
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Oedema peripheral
         subjects affected / exposed
    9 / 1032 (0.87%)
         occurrences all number
    11
    Pain
         subjects affected / exposed
    15 / 1032 (1.45%)
         occurrences all number
    15
    Peripheral swelling
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Thirst
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    50 / 1032 (4.84%)
         occurrences all number
    56
    Ulcer
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Psychiatric disorders
    Abnormal dreams
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    4
    Aggression
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Agitation
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Anxiety
         subjects affected / exposed
    23 / 1032 (2.23%)
         occurrences all number
    24
    Bulimia nervosa
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Bipolar I disorder
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    2
    Confusional state
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Depressed mood
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Depression
         subjects affected / exposed
    20 / 1032 (1.94%)
         occurrences all number
    21
    Euphoric mood
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Dysphoria
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Disorientation
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hallucination
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Hallucination, auditory
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Initial insomnia
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    32 / 1032 (3.10%)
         occurrences all number
    35
    Libido decreased
         subjects affected / exposed
    3 / 1032 (0.29%)
         occurrences all number
    3
    Irritability
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Libido disorder
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Mental disorder
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Mood altered
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Nervousness
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Sleep disorder
         subjects affected / exposed
    4 / 1032 (0.39%)
         occurrences all number
    4
    Stereotypy
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Thinking abnormal
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Stress
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Tic
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Withdrawal syndrome
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Amenorrhoea
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Bartholin's cyst
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number
    1
    Benign prostatic hyperplasia
         subjects affected / exposed
    2 / 1032 (0.19%)
         occurrences all number
    2
    Breast cyst
         subjects affected / exposed
    1 / 1032 (0.10%)
         occurrences all number